A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3) - Full Text View

Sponsor:	Shire Human Genetic Therapies, Inc.
Information provided by (Responsible Party):	Shire Human Genetic Therapies, Inc.
ClinicalTrials.gov Identifier:	NCT00912093

Purpose

This study is being conducted to evaluate the efficacy of icatibant compared to placebo in patients experiencing acute attacks of hereditary angioedema (HAE).

Condition	Intervention	Phase
Hereditary Angioedema	Drug: Icatibant Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase III Randomized, Double-Blind,Placebo-Controlled, Multicenter Study of Icatibant for Subcutaneous Injection in Patients With Acute Attacks of Hereditary Angioedema (HAE)

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary angioedema Help Me Understand Genetics

Drug Information available for: Icatibant Icatibant acetate

U.S. FDA Resources

Further study details as provided by Shire Human Genetic Therapies, Inc.:

Primary Outcome Measures:

Time to symptom relief for an acute attack, as assessed by the patient [ Time Frame: Patients monitored for a minimum of 8 hrs or until stable ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in VAS score from pretreatment [ Time Frame: 2, 4 and 8 hours post-treatment ] [ Designated as safety issue: No ]
Evaluation of global outcome of treatment using symptom severity score (by patient and investigator) [ Time Frame: Up to 5 hours post-treatment ] [ Designated as safety issue: No ]
Assessment of global improvement(by patient and investigator) [ Time Frame: 4 and 8 hours post-treatment ] [ Designated as safety issue: No ]
Global assessment of symptoms (by investigator) [ Time Frame: 2, 4 and 8 hours post-treatment ] [ Designated as safety issue: No ]
Time(s) to initial symptom improvement and almost complete symptom relief [ Time Frame: Up to 5 days post-treatment ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: Up to 14 days post-treatment ] [ Designated as safety issue: Yes ]
Time to reduction in symptom severity of laryngeal attacks [ Time Frame: Up to Day 5 post-treatment ] [ Designated as safety issue: No ]
Time to onset of symptom relief using VAS [ Time Frame: Patients monitored for a minimum of 8 hrs after first attack ] [ Designated as safety issue: No ]
Time to onset of symptom relief for first attack using composite VAS for non-laryngeal and mild-moderate laryngeal attacks [ Time Frame: Patients monitored a minimum of 8 hrs after first attack ] [ Designated as safety issue: No ]
Time to symptom relief using composite VAS for mild-moderate laryngeal attacks [ Time Frame: Patients monitored for a minimum of 8 hrs after first attack ] [ Designated as safety issue: No ]

Estimated Enrollment:	88
Study Start Date:	June 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Single subcutaneous injection of matching placebo	Drug: Placebo Single subcutaneous injection of matching placebo
Experimental: Icatibant Single subcutaneous injection of icatibant, 30 mg	Drug: Icatibant Single subcutaneous injection of icatibant, 30 mg Other Name: Firazyr

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Each patient must meet the following criteria to be enrolled in this study.

The patient is ≥18 years old at the time of informed consent.
The patient has a documented diagnosis of HAE type I or II. The diagnosis will be confirmed either by documented decreased C4 levels and/or immunogenic or functional C1-INH deficiency results (<50% of normal levels) consistent with HAE types I and II or by medical history.
The current HAE attack must be in the cutaneous, abdominal and/or laryngeal (inclusive of laryngeal and pharyngeal) areas.
Cutaneous or abdominal HAE attacks must be moderate to very severe as determined by investigator global assessment at pre-treatment assessments
The patient must report at least 1 VAS score ≥ 30mm
The patient commences treatment within 6 hours of the attack becoming at least mild (laryngeal) or moderate (non-laryngeal) in severity, but not more than 12 hours after the onset of the attack.
Women of childbearing potential must have a negative urine pregnancy test and must use appropriate methods to prevent pregnancy during their participation in the study.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study.

The patient has a diagnosis of angioedema other than HAE type I or II.
The patient has received previous treatment with icatibant.
The patient has participated in a clinical trial and has received treatment with another investigational medicinal product within the past 30 days.
The patient has received treatment with any pain medication since the onset of the current angioedema attack.
The patient has received replacement therapy (fresh frozen plasma [FFP], C1-INH products) less than 5 days (120 hours) from the onset of the current angioedema attack.
The patient is receiving treatment with angiotensin converting enzyme (ACE) inhibitors.
Evidence of coronary artery disease based on medical history or screening examination in particular unstable angina pectoris or severe coronary heart disease;
The patient has a serious concomitant illness or condition that, in the opinion of the Investigator, would be a contraindication for participation in the trial.
The patient is pregnant or breastfeeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912093

Show 64 Study Locations

Sponsors and Collaborators

Shire Human Genetic Therapies, Inc.

Investigators

Study Director:

Bradley Bloom, M.D.

Shire Human Genetic Therapies, Inc.

More Information

No publications provided by Shire Human Genetic Therapies, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lumry WR, Li HH, Levy RJ, Potter PC, Farkas H, Moldovan D, Riedl M, Li H, Craig T, Bloom BJ, Reshef A. Randomized placebo-controlled trial of the bradykinin B? receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: the FAST-3 trial. Ann Allergy Asthma Immunol. 2011 Dec;107(6):529-37. Epub 2011 Oct 5.

Responsible Party:	Shire Human Genetic Therapies, Inc.
ClinicalTrials.gov Identifier:	NCT00912093 History of Changes
Other Study ID Numbers:	HGT-FIR-054
Study First Received:	June 2, 2009
Last Updated:	September 8, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Shire Human Genetic Therapies, Inc.:

HAE
Type I HAE
Type II HAE

Additional relevant MeSH terms:

Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
Icatibant
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012